Application Guide for Production

An application for contained production with GMOs has to be written such that it lives up to the executive order of approval of production with genetically modified microorganisms and the executive order of production with genetically modified plants and animals.

An application form for production with and of GMOs can be found for:

Approval of production facilities and new production with GMO

Approval of production in already approved production facilities

A risk assesment must be attached to the application. The Danish Environmental Protection Agency have worked out a form for the risk assessment.

Risk assesment in connection to production with GMO

An application for contained production with GMOs has to be written such that it lives up to the executive order of approval of production with genetically modified microorganisms and the executive order of production with genetically modified plants and animals. Attention must be paid to the requirements in the executive orders. Below, is a list that can be used as a guidance to write the application. Notice the list is meant as guidance to fill out the application. The application are always to comply with the executive orders found on the page "Regulation".

List of requirements:

  • Name of the company/institution and the personnel who are responsible for inspection, safety, as well as their qualification and education.
  • The address of the production facilities and a general description of the buildings.
  • A general description of the work related to the GMO.
  • The classification of the contained work. Read more on criteria for classifications.
  • A description of the applied recipients, donors, parent organisms and used host-vector systems.
  • The origin of the genetic material involved in the modification and the aim function of the product organism.
  • The identity and charateristics of the GMO.
  • The purpose of the contained use of the organism and the expected results.
  • Estimated volume of the culture.
  • A description of the planned containment- and other protective measures to avoid accidental release.
  • Information on the kind of wastes produced, on how to inactivate the wastes and how it is disposed of without contamination of the surrounding environment.
  • A risk assessment related to the environment, nature and health. For more information on risk assesment.
  • Information on specific risks assigned to the location of the facility.
  • The precautionary measures such as safety features, a warning system and procedures to prevent an accidental release of the GMO.
  • Procedures and plans to control the systems setup to prevent release are still active and effective.
  • A description of the information given to the personnel working with GMO or in the facilities.

If the production are considered specifically hazardous to the surrounding environment, an emergency plan must be prepared before the production is started. A copy of the emergency plan must be send to the EPA. For more information look on emergency plan

For more information on the requirements read the executive order on approval of production with genetically modified organisms (In Danish) and the executive order on approval of production with genetically modified plants and animals (In Danish).

The application can be send to:

The EPA post box:

Or

Pesticider og Biocider

Miljøstyrelsen

Tolderlundsvej 5

5000 Odense

Att. GMO Production

Review Process of Applications and Permanence of the Approval

The review process of applications regarding a production of class 1 or 2 will be settled within 45 days from the day the full application with all details are received. When a company, who already have approved facilities for production with GMO, applies for production with a new organism, the production can begin 14 days from the day the EPA receives a full application with all details, if the production is a class 1, unless the EPA inform different on the matter.

A permanence of the approval lasts 8 years.

Consultation

The EPA are obligated to carry out consultations of the neighbors to the production facility who have sent an application for production with GMO. The procedure is to make an announcement on the matter on the EPA homepage.